GMP and Regulatory Expectations for Early IND Products
Date & Time: April 05th and April 06th 2012
9 AM PDT to 5 PM PDT
Duration: 2 Days
Instructor: Steven S Kuwahara
Location: San Diego
Price : $1695.00
Instructor Profile: Steven S Kuwahara Founder & Principal, GXP Biotechnology, LLC
Overview: Any pharmaceutical worker who must deal with products both in early and latter phases of development should attend this course in order to be aware of the regulatory requirements that will affect
Steven S. Kuwahara, Ph.D. is the founder and Principal of GXP BioTechnology LLC, a consulting firm that works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals. Steve has over 30 years of experience in supervising quality control laboratories, including an animal testing facility, and in performing GLP and GMP audits of internal and external testing laboratories . Steve has participated in the development of drugs and biologicals through all phases of clinical research and final product production. ...more
operations dealing with these products. Any pharmaceutical worker who must deal with products both in early and latter phases of development should attend this course in order to be aware of the regulatory requirements that will affect operations dealing with these products. The modifications to the GMPs for early phase products have modified the GMPs in such a way as to reduce requirements to allow more efficient work. At the same time some of the things that may appear to have changed, have not, and the pharmaceutical worker should be aware of this. This course will present, in one place, the regulations and guidelines that apply to early phase products. In some cases these will not be regulations, but needs that, if met, will increase the efficiency of activities as a product proceeds through the development process. The course will present these items in the order of product development from the point of R & D activities to the completion of Phase 2 clinical trials.
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Areas Covered in the Session:
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Day 1, April 5, 2012 Lecture 1: Very Early Stages l
The need for documentation of matters that will affect downstream work.
The effects of ICH Q8 ¡ Impact on R & D activities ¡ Risk analysis and design control at this stage.
Lecture 2: GLP Requirements l
¡ Toxicology and pharmacokinetics. Estimating the Maximum Safe Starting Dose ¡ A review of the guidance document.
Lecture 3: Early Pre-IND Studies l
Understanding exploratory Studies ¡ Definitions and the IND that will be withdrawn. Orphan Drugs Drugs studied under the Animal Rule ¡ What they are and how to conduct the studies.
Lecture 4: Meetings and Preparing for the IND l
Information required for the Phase 1 IND ¡ The CMC requirements that will be needed. Pre-IND Meetings with FDA
Day 2, April 6, 2012 Lecture 5: GMPs for Phase 1 IND products l
The scope of the guidance document
The second guidance document covering the GMPs.
Lecture 6: GMPs for Phase 1 continued l
A presentation covering what GMPs are required at this stage.
What has been omitted from the GMPs for Phase 1.
Lecture 7: Requirements for Phase 2 INDs l l l
The full GMPs resume, but do they? Phase 2 studies and the transition to full GMPs. CMC requirements.
Lecture 8: Preparing for IND Meetings l
Phase 1 meetings
Pre-phase 2 meetings Phase 2 meetings
Click here to register for this webinar Who Will Benefit: l l l l l
Directors Managers Supervisors, and lead workers in Regulatory Affairs Quality Assurance and Quality Control Workers who will prepare GMP documents for early phase products as well as those who will review these documents Regulatory affairs workers who will need to deal with submissions covering early phase products.
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel
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